Friday, December 7, 2007

Learn about new trials

We all know about standard treatment trials, but have we all heard about these new trials:

Other Types of Trials

Adjuvant and Neoadjuvant Treatment Trials

Adjuvant trials are additional therapy after standard treatment. They are designed to prevent the recurrence of cancer in people who no longer show clinical evidence of disease. Adjuvant trials attempt to treat the subclinical or microscopic disease thought to be responsible for cancer recurrence and therefore improve disease-free and overall survival. The combination of standard and adjuvant treatments is initially tested in a small feasibility or pilot study similar to a single-agent phase 2 trial. This is followed by a randomized phase 3 trial if the combination proves safe and effective.

Neoadjuvant trials are additional therapy before standard treatment. These trials evaluate treatments designed to reduce tumor size to a point where it can be definitively treated by therapies that are considered the best standard treatment. For example, clinical trials have shown that chemotherapy can reduce an inoperable breast cancer to a size that can be removed surgically.

Both adjuvant and neoadjuvant trials are phased like other treatment protocols, with the phase dependent on the major objective of the trial.

Prevention Trials

Cancer prevention trials are designed for people at risk of developing cancer. The trials evaluate the safety and effectiveness of various risk reduction strategies. The two types of prevention trials answer the following questions:

  • Action trials: Can a person's actions - such as exercising more or quitting smoking - prevent cancer?

  • Agent trials: Can taking certain medicines, vitamins, minerals, or food supplements lower the risk of certain types of cancer?

(Agent trials are also known as chemoprevention trials.)

Chemoprevention trials compare a promising new prevention agent or technique with a standard agent or technique, or placebo. The investigational group takes the agent being studied; the control group takes either the standard agent that is being compared to the study agent or - because there may be no standard agent - a look-alike agent that contains no active ingredient, called a placebo.

Screening Trials

Screening trials assess the effectiveness of new means of detecting the earliest stages of cancer. In addition, these trials examine whether early treatment improves overall survival or disease-free survival. Screening tools include imaging tests and laboratory tests.

Diagnostic Trials

Diagnostic trials develop better tools for physicians to use in classifying types and phases of cancer, and in managing the care of people with cancer. Some trials compare the ability of two diagnostic techniques to provide information about a suspected cancer. Genetic tests are being evaluated as diagnostic tools to classify cancers further, thus helping physicians direct cancer therapy and improve treatments for people with specific genetic mutations. Diagnostic trials may also evaluate techniques designed to measure and monitor cancer response more accurately or less invasively, such as using a new imaging tool that eliminates the need for surgery.

Genetics Trials

Actual genetic intervention (such as gene-transfer) trials are few in number, however trials are underway where actual cellular manipulation at the gene level occurs. Most genetics research involves looking at tissue or blood samples from large populations of people in order to determine how genetic make-up can influence detection, diagnosis, prognosis, and treatment. This genetic epidemiologic research does not involve any actual intervention. Rather, it is designed to broaden understanding of the causes of cancer. Genetics research is also being used to develop targeted treatments based on the genetics of a tumor.

Genetics research is a critical component of cancer research because it helps scientists understand the causes of cancer and can lead to developing clinical trials for the prevention, detection, and treatment of cancer.

Quality-of-Life and Supportive Care Trials

Quality-of-life and supportive care trials test interventions designed to improve quality of life for people with cancer and their families. They seek better therapies or psychosocial interventions for people experiencing nutrition problems, infection, pain, nausea and vomiting, sleep disorders, depression, and other effects of cancer or its treatment. Some supportive care trials target families and caregivers to help them cope. The effectiveness of supportive care trials may be measured either:

  • Subjectively: Is the person's pain reduced?

  • Objectively: Are the white blood cell counts improved?

1 comment:

Anonymous said...

I think the therapy of clinical trials presented is worth reading.